Hair dye and hair colour are cosmetics under the Cosmetics Rules, 2020 and must be registered with CDSCO before import. The category is technically straightforward — the standard depends on whether the product is a liquid, an emulsion, a powder or henna — but it carries the most demanding labelling obligation of any cosmetic, driven by the para-phenylenediamine (PPD) sensitisation risk.
The application is Form COS-1, granted as Form COS-2. What decides a clean approval here is not the chemistry but the caution: the statutory PPD warning must appear in full, legibly, on the outer pack. A missing, abbreviated or illegibly small caution is the single most common label rejection for this category.
📌 The PPD caution is mandatory and specific: the product may cause serious inflammation of the skin in some persons, a patch test should be carried out 24 hours before use, and it must not be used for dyeing eyelashes or eyebrows as it may cause blindness. It must be conspicuous on the outer pack, not buried in the insert.
📋 Is CDSCO Registration Mandatory for Hair Dye & Hair Colour?
Yes. Hair dye and hair colour are cosmetics within the Fourth Schedule category of hair-care preparations, and import registration is mandatory. The applicable Indian Standard depends on the format.
Two-part oxidation kits (colour plus developer) need both parts covered in the authorisation and the Free Sale Certificate, and a hydrogen-peroxide concentration declaration for the developer.
📘 The Indian Standard That Applies
The Ninth Schedule points hair dye to different standards by format: IS 8481 for liquid oxidation hair dyes, IS 15205 for emulsion-type oxidation hair dyes, IS 10350 for powder hair dye and IS 11142 for henna powder. The Certificate of Analysis must be drawn against the standard for the format actually imported.
The dossier must also declare the concentration of para-phenylenediamine (PPD), para-toluenediamine and other dye intermediates, the hydrogen-peroxide concentration of the developer where a two-part kit is supplied, the ammonia content, and heavy-metal results — along with a skin-sensitisation or patch-test protocol.
🗂️ Documents Required for Hair Dye & Hair Colour
Every Form COS-1 application carries the same core set — covering letter; First Schedule authorisation; Part-I of the Second Schedule; ingredient list with percentages; inner and outer labels; specification and method of testing; finished-product Certificate of Analysis; country-of-origin manufacturing licence or marketing authorisation; original Free Sale Certificate; non-animal-testing declaration; heavy-metal and hexachlorophene declaration; GMP / ISO 22716 certificate; correlation chart; Bharatkosh receipt; and the signed Form COS-1. On top of that base, this product needs:
- Certificate of Analysis against the applicable IS for the format — IS 8481 (liquid), IS 15205 (emulsion), IS 10350 (powder) or IS 11142 (henna).
- Concentration declaration for para-phenylenediamine (PPD), para-toluenediamine and other dye intermediates.
- Hydrogen-peroxide concentration for the developer, where supplied as a two-part kit.
- Skin-sensitisation / patch-test protocol.
- Pack insert containing the patch-test instructions, submitted as part of the dossier.
- Ammonia-content declaration and heavy-metals report.
🏷️ Product-Specific Label Requirements
Hair-dye labels carry the tightest requirements of any cosmetic category:
- The statutory caution for dyes containing PPD or dye intermediates — warning of possible serious skin inflammation, advising a patch test 24 hours before use, and warning against use on eyelashes or eyebrows as it may cause blindness.
- Clear directions for mixing and contact time.
- The caution printed conspicuously on the outer pack, not only in the insert.
- The general Chapter VI content — manufacturer or “Made in”, batch number, expiry and RC number.
🛠️ Step-by-Step Registration Process
- Classify the productConfirm the article meets the definition of a cosmetic under Section 3(aaa) and is not a drug, then map it to the correct category under the Fourth Schedule — this drives both the fee and the certificate scope.
- Appoint the Authorised Indian AgentExecute the authorisation in the format of the First Schedule, signed jointly by the manufacturer and the agent on every page, then notarised and apostilled (Hague states) or attested by the Indian Embassy.
- Assemble the technical dossierIngredient list with percentages, specification and method of testing, finished-product test reports, inner and outer labels, GMP / ISO 22716 evidence and the Free Sale Certificate.
- Align the label to Chapter VIIndian labelling is one of the top rejection reasons. India-specific content may be stickered onto the unit pack at a bonded warehouse before clearance.
- Pay the fee on BharatkoshCompute the category, site and variant fees, pay online under head 0210041040000-00-1 and retain the Bharatkosh acknowledgement receipt for upload.
- File Form COS-1 on SUGAMUpload the full checklist, including the correlation chart that ties each product serial number in COS-1 to the Free Sale Certificate and the authorisation.
- Respond to CDSCO queriesQueries typically concern apostille defects, Free Sale Certificate scope mismatch, ingredient limits and label non-compliance. Reply within the stipulated period.
- Receive Form COS-2Print the Registration Certificate number on every unit pack, alongside the holder’s name and address, before the goods are cleared for sale.
💰 Government Fees
CDSCO cosmetic registration is priced under the Third Schedule and paid product-family by product-family, not as a single flat licence. The headline components are:
Each cosmetic category
USD 1,000 for the grant or retention of the Registration Certificate, per Fourth Schedule category.
Each additional category
USD 1,000 for every further category of cosmetic added to the same application.
Each variant
USD 50 for each shade, fragrance or formulation variant declared.
Each manufacturing site
USD 500 for every overseas manufacturing premises covered by the certificate.
Fees are paid online through the Bharatkosh gateway under head of account 0210041040000-00-1, and the acknowledgement receipt is uploaded with the application. As a worked example, an importer registering one category from a single factory with six shade or fragrance variants would pay USD 1,000 (category) + USD 500 (site) + 6 × USD 50 (variants) = USD 1,800 in government fees, before professional and testing costs. Inspection of an overseas site, if ordered, is a further USD 5,000.
⏱️ Timeline & Validity at a Glance
A complete, well-drafted application is typically cleared in about four to six months. The single biggest lever on that timeline is the quality of the first filing: every query CDSCO raises effectively restarts the clock, so a dossier that pre-empts the common objections is worth far more than one filed quickly and corrected later. The certificate is valid for five years and should be re-registered before expiry — an application filed after lapse is treated as a fresh registration.
⚠️ Where Applications Usually Get Queried
Hair-dye queries are dominated by the caution and the two-part kit:
- The mandatory PPD caution missing, abbreviated or printed in an illegible size — the single most common label rejection for this category.
- Two-part kits where both parts are not covered in the authorisation and the Free Sale Certificate.
- Missing hydrogen-peroxide, ammonia or PPD-intermediate concentration declarations.
- No skin-sensitisation or patch-test protocol in the dossier.
🔗 Related Approvals Alongside CDSCO
Alongside the CDSCO registration, imported hair dye usually needs:
- Importer-Exporter Code (DGFT) — mandatory for any importer of record, obtained before the first consignment.
- LMPC registration (Legal Metrology) — importers of pre-packaged commodities must register under the Legal Metrology (Packaged Commodities) Rules, 2011 and carry MRP, net quantity, importer details, country of origin, consumer-care details and date of import on the pack.
- Wholesale drug licence (Form 20B / 21B) — where the Indian agent also distributes drugs alongside cosmetics.
- Drug import licence (Form 10) — if the product contains a pharmacologically active ingredient or carries a therapeutic claim, it is a drug, not a cosmetic, and this route no longer applies.
❓ Frequently Asked Questions
What exactly must the hair-dye caution say?
It must warn that the product may cause serious inflammation of the skin in some persons, advise that a patch test be carried out 24 hours before use, and warn that it must not be used for dyeing eyelashes or eyebrows because it may cause blindness. It must be conspicuous on the outer pack.
Why was my hair dye rejected on labelling?
Most often because the mandatory PPD caution was missing, abbreviated or printed too small to read. This is the single most common label rejection for the category, and it applies even when the chemistry is fully compliant.
How is a two-part colour-and-developer kit handled?
Both parts must be covered in the authorisation and the Free Sale Certificate, and the hydrogen-peroxide concentration of the developer must be declared. The kit is registered as a unit, but each component has to be documented.
Is CDSCO registration mandatory to import hair dye & hair colour into India?
Yes. Under Rule 12(1) of the Cosmetics Rules, 2020, no cosmetic may be imported into India unless the product is registered with the Central Licensing Authority. The registration is granted product by product in Form COS-2 and must be in place before the first consignment lands.
Which form and portal are used?
The application is Form COS-1, filed online on the CDSCO SUGAM portal by the overseas manufacturer or, far more commonly, by an Authorised Indian Agent. The approval is issued as an Import Registration Certificate in Form COS-2.
How long does registration take and how long is it valid?
A complete application is usually cleared in about four to six months, and each CDSCO query effectively restarts the clock. The certificate is valid for five years from the date of issue and must be re-registered before it lapses.
Do we need an Indian agent?
Almost every application is filed through an Authorised Indian Agent, appointed on the First Schedule format. The agent carries statutory liability for the product in India even after the power of attorney is withdrawn, so this is a substantive appointment, not a formality.
Hair-Dye Import Registration, With the Caution Done Right
Global Approbation manages CDSCO registration for imported hair dye and hair colour — format-specific IS review, PPD and developer declarations, patch-test inserts and the statutory caution vetted to the letter — so the most label-sensitive category clears first time.
Talk to Our CDSCO Team Global Market Access